Validation Engineer

Hillsboro Technical Operations (HTO), located in Hillsboro Oregon, is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world.

The Opportunity:

In this exciting role, you will be accountable for performing activities such as Equipment Commissioning and Qualification, Cycle Development (CD), Performance Qualification (PQ) and Re-Qualification (RPQ) / Cleaning Validation (CV) and Process Validation (PV) in support of technology transfer and new technology introduction to the HTO site.

• You will closely collaborates across the site and occasionally works with other network organizations

• You will focus on right first time execution and continuous improvement

• You will execute, and manage the detailed project plans and timelines for the execution of CD/IQ/OQ/PQ/CV/PV/RV activities.

• You will prepare change control documentation, including protocols, summary reports, etc., for all activities.

• You will ensure new systems are implemented within predetermined timelines and financial forecasts.

• You will present and provide rationale for the completed work during periodic audits and Health Authority inspections.

• You will coordinate and perform tactical activities, including sample collection, coordinating with cross-functional support teams, retrieving data and results, completing documentation, as required per protocols

• You will lead change management system for new processes, equipment, utilities and facilities.

• You will foster an environment that encourages continuous learning. Maintain expertise as necessary to stay abreast of technical and industry advancements.

• You will manage the development and implementation of novel approaches to solving complex technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production.

• You will utilize Lean Production System elements and methods to continuously improve Engineering tactical business processes and procedures.

Who you are:

• You hold BS/MS in chemical, biochemical engineering, or related field/experience, with a minimum of 0-3 years experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services is required.

• You have experience in the pharma/biotech industry

• You have working knowledge of cGMPs or equivalent regulations

• You have working knowledge of facilities, utilities, formulation, filling, and packaging, equipment qualification in a regulated environment is required.

• You have demonstrated project management skills

• You have the ability to work with internal teams, partners, suppliers and customers

• You have opperational excellence and industrial engineering skills are a plus

• You have professional level written and oral communication skills required

The expected salary range for this position based on the primary location for this position of Hillsboro, OR is $80,500 - $149,500. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Please note this role is eligible for relocation benefits.

Link to Roche/Genentech Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

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